Clinical trial recruitment plan template

What is a clinical trial recruitment plan?

A recruitment plan is the written answer to how a study will reach its enrollment target. Sponsors usually write one for the whole study; each site needs its own version, because the patients, staff and referral partners are local. ICH E6(R3) expects the investigator to be able to demonstrate, for example from retrospective or current data, a potential for recruiting the agreed number of eligible participants within the recruitment period, and it lists reviewing recruitment and retention rates as part of monitoring.^⁠[1] CTTI's recruitment recommendations ask study teams to set realistic expectations for enrollment and to map out anticipated events early, even with rough estimates, to find bottlenecks.^⁠[2]

Even trials that meet their goals usually run late: Tufts CSDD found that reaching enrollment targets typically means nearly doubling the original timeline.^⁠[3] A methods paper on accrual planning puts the cause plainly: projected recruitment rates are often over-estimated, and the time to recruit is often under-estimated.^⁠[6] A plan built from your own data, with a named owner for each source, is the defense against both.

How should you use the template?

1. 1

   Start from the target and work backward

   Write down how many patients the site must randomize and by when, then use the funnel worksheet to find how many candidates that takes.

2. 2

   Put a count and an owner next to every source

   Records, referrals, advertising and registries each get an expected number, a person responsible and a start date.

3. 3

   Get the materials approved before outreach starts

   Ads, scripts, text messages and landing pages go to the IRB with the rest of the recruitment package.

4. 4

   Plan retention at the same time

   A patient who drops out after randomization has to be replaced, so the plan covers keeping patients as well as finding them.

5. 5

   Review the funnel weekly and re-forecast

   Once real numbers come in, replace the assumed rates with actual ones and update the plan.

How do you work backward from the enrollment target?

Divide the target by each stage's conversion rate, starting from randomization and moving up the funnel. Use your own screening log and outreach history for the rates. Where you have no history, say so and choose a cautious assumption rather than the sponsor's estimate.

Where will the patients come from?

List every source with a count, not a hope. For most sites the first source is their own records. Reviewing records to judge whether enough patients exist is usually handled under the HIPAA provision for reviews preparatory to research, which requires that no protected health information leave the covered entity during the review.^⁠[8] The feasibility questionnaire template has a worksheet for turning a diagnosis count into a likely-eligible count.

Advertising works on a different clock from records: leads arrive whenever the ad runs, and they cool quickly. Our posts on running Meta ads for clinical trials and speed to lead cover the setup and the follow-up.

What outreach needs IRB approval before it starts?

Recruitment materials are reviewed before they are used. FDA's guidance treats direct advertising for study subjects as the start of the informed consent and subject selection process, and says advertisements should be reviewed and approved by the IRB.^⁠[9] ICH E6(R3) asks for a documented, dated IRB approval of participant recruitment procedures, such as advertisements, before the trial starts.^⁠[1]

• Ads, flyers, posters and social media posts
• Landing page and online pre-screening questionnaire
• Phone script and voicemail (pre-screening call script template)
• Text messages (patient outreach SMS templates)
• Letters and emails to patients and referring physicians
• AI disclosure wording, if an AI agent calls or texts (IRB language template)
• Translated versions of each item, for every language you will recruit in

Automated calls and texts carry their own consent rules under the TCPA, and contacting a site's own patients raises HIPAA questions about who may reach whom. The IRB and HIPAA guide to patient outreach and our TCPA post on AI outreach cover both.

What goes in the retention plan?

Retention belongs in the same document because it uses the same funnel: every randomized patient who drops out has to be replaced from the top. E6(R3) treats the two together, listing recruitment and retention rates among the things monitoring reviews.^⁠[1]

• Visit reminders by the patient's preferred channel (why screening visits get missed)
• Transportation, parking and travel reimbursement, arranged before the first visit
• Participant payments and when they are made, as approved by the IRB
• Scheduling that fits work and caregiving, including early or late appointments where possible
• A named study contact the patient can reach between visits
• Check-ins between visits for side effects and questions
• A rule for spotting patients at risk of dropping out, such as missed calls or a rescheduled visit, and who follows up

Who owns each task, and what will it cost?

Our guide to what recruitment software costs compares the common fee models.

How do you know if the plan is working?

When the funnel stalls, the stage where it stalls points to the fix: few candidates means a sourcing or criteria problem, low reach means contact timing or channels, and high screen failure means candidates are not being checked carefully enough before the visit. Our guide to reducing screen failure covers the last one.

Where does Bond fit?

Bond Health does not write recruitment plans. It runs the parts of one that take the most coordinator time. Identify screens structured and unstructured EHR records against a study's inclusion and exclusion criteria and shows the chart evidence behind each criterion decision. Engage runs voice and SMS outreach, pre-screening and scheduling, with scripts configured per site and study so it can use the wording the site's IRB approved. For studies that need patients beyond the site's records, Bond creates and runs Meta and Google ad campaigns, contacts every ad lead immediately and follows up until they respond.^⁠[10],[11]

After randomization, Bond sends visit reminders, books transportation, runs side-effect check-ins and flags patients at risk of dropping out.^⁠[11] Full EHR integration usually takes 48 hours, depending on the EHR, IT review and interface method.^⁠[10] See Bond for research sites, or browse the other templates.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each patient's randomization milestone payment.^⁠[10],[11]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[10]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[11]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[10],[11]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[10],[11]
• No integration fee, and a price that moves with randomization. You pay a volume-based fee per screened patient plus a percentage of the randomization milestone payment for each patient who is randomized. See pricing.^⁠[11]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.